Post Discharge Nurse-led Rehabilitation to Improve Self-care Among Stroke Patients in Bangladesh: A Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Hiroshima University
- Enrollment
- 64
- Primary Endpoint
- Change in the functional independence of activity of daily living
Study Overview
Brief Summary
Stroke causes various levels of disability, which decreases physical function for a prolonged period. The purpose of this study is to test the feasibility and efficacy of a nurse-led rehabilitation program focused on improving the activity of daily living (ADL) among post-stroke patients in Bangladesh. A feasibility study, including descriptive and randomized controlled trial (RCT), will be conducted at the National Institute of Neuroscience & Hospital (NINS&H) in Dhaka, Bangladesh, from March 2025 to August 2025. Participants will be the post-stroke patients who got discharged from NINS&H from 5th days to 2 weeks after the onset of stroke and the family caregivers of the patients and meet the inclusion criteria. The sample size will be calculated based on G-Power analysis with a medium effect size and will be 64. The intervention will be designed to provide the 3-month nurse-led rehabilitation program regarding self-care and the use of assistive devices. Assessment for rehabilitation will be performed by the multidisciplinary team with research nurses (RA nurses), physiotherapists (PT), and occupational therapists (OT). The control group will receive the usual care. The Functional Independence Measure (FIM) measures the primary outcome as improved self-care. The secondary outcomes are self-efficacy and participation in social activities for patients and the care burden of family caregivers. We also qualitatively describe changes and improvements of cognitive, emotional, and behavioral aspects among patients and their families. The endpoints will be compared at baseline and the 3rd month. Rehabilitation with proper assistive devices may improve self-dependence, ADL, and social participation. The caregiver's burden will decrease through the implementation of self-care education and assistive devices for daily life adjustment.
Detailed Description
Stroke is considered the second most leading cause of death and disability across the globe. According to Bangladesh Sample Vital Statistics 2022, the prevalence of disability is 25.5/1000 population. Almost 70% of strokes occur in lower middle-income countries (LMICs), resulting in increased disease burden than high-income countries. Patients are often the breadwinners, and their families lose their financial footing due to treatment costs and disability, leading to economic deprivation.
Stroke rehabilitation has many barriers, including scarcity of human resources, infrastructure, finances, clinical guidelines, and national policy to support such intervention to reduce the disease burden, which is evident worldwide but much more prominent in low- and middle-income countries (LMCs). According to WHO (2019), < 10/1 million people are skilled in rehabilitation.
The purpose of this study is to test the feasibility and efficacy of nurse-assisted rehabilitation programs focused on improving the activity of daily living among post-stroke patients in Bangladesh. It can be assumed that if the nurse-assisted rehabilitation service is provided within a short time of stroke onset, the prognosis will be better, the patient will be self-dependent, the disease burden will be less, and the patient will be free of complications during post-stroke time.
A pilot randomized control trial (RCT) study will be implemented. The investigators will qualitatively and quantitatively explore the acceptance of home rehabilitation and the use of assistive devices for functional independence among post-stroke patients and their family caregivers. Investigators will also describe cognitive and emotional changes (awareness, motivation, and self-efficacy), behavior, functional changes, and social participation.
The study will be conducted at the National Institute of Neurosciences & Hospital, Dhaka, Bangladesh (NINS&H), and patients' homes. The study area is within and near the Dhaka district to reach the study participants and observe them. The study participants will be the post-stroke patients and their caregivers. The written informed consent will be taken from patients and caregivers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •For Patient
- •who is 18 years old and above, both males & females,
- •is irrespective of type of stroke and time of stroke,
- •is within 5 days to 2 weeks of onset of the current stroke
- •Physician advice rehabilitation, and who needs assistive devices for ADL,
- •has family caregivers,
- •lives in the study area, and
- •who will provide written consent & willing to participate in the study.
- •For family care giver
- •Primary caregivers irrespective of sex and aged 18 years old and above, living with the patient who take care of an above patient and who meets all the inclusion criteria.
- •Who will provide written consent & willing to participate in the study
Exclusion Criteria
- •For patient
- •Participation in other clinical trials,
- •not having a smartphone at home, For family care giver No exclusion criteria
Arms & Interventions
Assistive Device Intervention
Patients and caregivers will be trained in self-care with stroke disabilities (e.g. eating, grooming, bathing, dressing, toileting), physical exercise, lifestyle modification, prevention of complications after stroke through researcher developed "Health booklet". Based on their disabilities some adjustive and exercise devices will be provided to them for improving functional independence.
Intervention: Assistive Device and health Education (Behavioral)
Control Group
No "Education booklet" or adjustive device are provided to them. The patients with family caregivers in control group will receive the usual care.
Outcomes
Primary Outcomes
Change in the functional independence of activity of daily living
Time Frame: 3 months
Functional Independence Measurement (FIM) tool will be used. This scale has 18 items from level 1-Total assistance to level 7- Complete independence. The total score is 126, the lowest score is 18. A higher score means improved functional independence level and lower score means less functional independence.
Secondary Outcomes
- Patient's Social participation(3 months)
- Patient's Self-efficacy(3 months)
- Family Care burden(3 months)
Investigators
Salma Akhter
Doctoral Researcher
Hiroshima University